Production leptospirosis vaccine with included strain of Leptospira interrogans of serogroup Canicola

Abstract

Abstract The leptospirosis vaccine is the main method of preventing the occurrence and spread of leptospirosis. Compliance with the standards of manufacturing, labeling, and storage is mandatory for immunological preparations. All stages of vaccine production must comply with the rules established by the Ministry of Industry and Trade and ensure its safety for humans. The article presents epidemiological data on leptospirosis in the Russian Federation in the period from 2013 to 2018. A method for producing a vaccine against human leptospirosis is described. The leptospirosis vaccine is polyvalent using membrane technologies and semi-synthetic culture media. It eliminates the use of foreign protein and does not require cleaning. The vaccine is an opalescent liquid with sediment and a pH of 7.2-7.6 and it is not allowed to contain live leptospira. Four strains are used and a new strain has been developed and implemented. Vaccination is carried out according to epidemiological indicators. Leptospirosis suspension forms specific immunity for 1 year. During the production of the updated vaccine, it was necessary to study the virulent properties of the strains. Moreover, analyze the formation of specific antibodies to leptospira in the new vaccine and in the vaccine currently used. From 2018 to 2020, 5 series of experimental vaccines in the form of a 0.5 ml suspension were produced.